Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
42 participants
INTERVENTIONAL
2025-12-01
2027-07-31
Brief Summary
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Participants will be assigned to one of the two groups:
* Cognitive Strategies, Mindfulness, and Rehabilitation Therapy (C-SMART) is a recently developed virtual intervention combining both cognitive rehabilitation with mindfulness meditation training. The manualized program consists of 8 weekly 1:1 tele intervention sessions, targeting cognitive weaknesses identified from baseline cognitive testing.
* Brain health Education and Wellness (BE Well) intervention consists of 8 weekly videos focused on maximizing brain health in the context of brain tumor.
Participants will also be asked to:
* participate in two in-person visits involving an MRI and neurocognitive tests
* complete a survey the the beginning and end of the study
* if in BE Well group, answer a few questions after watching each video
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Cognitive Strategies, Mindfulness, and Rehabilitation Therapy (C-SMART)
Modular tele-neuropsychological rehabilitation blending both cognitive rehabilitation with integrated mindfulness meditation training.
C-SMART
Eight weekly, 45-60 minute, 1:1 tele-intervention sessions, targeting neurocognitive weaknesses identified from baseline cognitive testing
Brain health Education and Wellness (BE Well)
Time-matched educational videos focused on maximizing brain health in the context of brain tumor.
BE Well
Eight weekly 45- to 60-minute video lectures
Interventions
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C-SMART
Eight weekly, 45-60 minute, 1:1 tele-intervention sessions, targeting neurocognitive weaknesses identified from baseline cognitive testing
BE Well
Eight weekly 45- to 60-minute video lectures
Eligibility Criteria
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Inclusion Criteria
* Confirmed primary brain tumor diagnosis by histology or neuro-oncologist review of imaging
* At least one domain of neurocognitive function \>1.5 SD below the average or the individual's estimated premorbid functioning, using the expanded International Cognition and Cancer Task Force (ICCTF) clinical trials battery and Test of Premorbid Functioning62 for comparison; (3) \>1 month post brain surgery and/or radiation therapy, if applicable;
* Estimated premorbid intelligence \>75.
* Patients must be age 18+ and
* Primarily English speaking.
* Must enroll with a patient (see criteria above)
* Must be age 18+ and
* Primarily English speaking
Exclusion Criteria
* Inability to attend weekly telehealth appointments
* Clinically significant insomnia symptoms coupled with report that insomnia is more interfering than cognitive symptoms
* \< 1 month post brain surgery and/or radiation therapy
* Unstable internet connection or an inability to work teleconferencing software. Participants will be supplied an iPad if they do not have an adequate device.
* Participants cannot have metal in their body as the MRI scan could cause them harm
* If female of childbearing years, they cannot be pregnant as the MRI scan may pose risk to the unborn fetus
-N/A
18 Years
ALL
No
Sponsors
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American Psychological Foundation
OTHER
Virginia Commonwealth University
OTHER
Responsible Party
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Principal Investigators
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Sarah Braun, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University
Locations
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Virginia Commonwealth University
Richmond, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Sarah Braun, Ph.D
Role: primary
Other Identifiers
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HM300000218
Identifier Type: OTHER
Identifier Source: secondary_id
MCC-25-22557
Identifier Type: -
Identifier Source: org_study_id